PMCF study is carried out for CE certified medical devices that are placed in the market. It’s a method of proactive collection of clinical data to analyze the emergent risks/side-effects of the medical device to demonstrate the safety and performance as per the intended purpose, throughout the expected lifetime of the device.
Performance and safety parameters are predefined with acceptance criteria based on the benchmark devices data, and milestones are designed for several PMCF studies and activities. The literature screening and registries study also supports PMCF findings. The sample size is predefined as per the sales of the device to study the emergent risks. Benefit-risk ratio analysis is performed as per the PMCF findings, for the acceptability of the device in the market. The PMCF findings are also documented in Technical Documentation, Risk File, SSCP, CER and PSUR
PMCF Includes
- PMCF Procedure
- PMCF Plan
- PMCF Report
PMCF Plan
- PMCF Protocol
- Sample Size
- Design of Milestones with follow-up period
- Design of measurable endpoints for performance and safety
- Ethical Committee approval
- Questionnaire/Survey form
- Patient/subjects consent form
- Clinical Investigation/Trial procedure (if any)
- Real World Evidence
- Statistical Significance
PMCF Report
- Milestones completion
- Real World Evidence analysis
- Literature Screening
- Registries
- Questionnaires and Surveys results
- Feedback from users/end user
- Clinical Investigations/Trials results (if planned any)
- Outcome of performance and safety endpoints
- Risk benefit analysis
- Residual Risks (if any)
- Statistical Analysis
- CER citation
- Frequency of PMCF update
IZiel Healthcare offers PMS services to our clients where we perform end to end Post Market Surveillance activities. These services can be PMS Plan, PMS/PSUR Reports, PMCF Plan and Reports, Trend Reporting, Complaint Handling, Clinical Evaluation, Risk Benefit Management and many more.
We have expertise in designing PMCF Plan and drafting reports for our clients for all the Classes of Medical devices – Class IIa, Class IIb and Class III.
You may contact us at Contact Us – Iziel.
To know more about us, please check Who We Are – Iziel.
